Energy based fat reduction

ABSTRACT

Methods for non-invasive fat reduction can include targeting a region of interest below a surface of skin, which contains fat and delivering ultrasound energy to the region of interest. The ultrasound energy generates a thermal lesion with said ultrasound energy on a fat cell. The lesion can create an opening in the surface of the fat cell, which allows the draining of a fluid out of the fat cell and through the opening. In addition, by applying ultrasound energy to fat cells to increase the temperature to between 43 degrees and 49 degrees, cell apoptosis can be realized, thereby resulting in reduction of fat.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/646,609, filed Dec. 23, 2009, which is a continuation-in-part of U.S.application Ser. No. 11/163,154, filed on Oct. 6, 2005, now U.S. Pat.No. 8,133,180, issued Mar. 13, 2012, which claims the benefit ofpriority to U.S. Provisional No. 60/616,753, filed on Oct. 6, 2004, eachof which are hereby incorporated by reference in their entirety herein.In addition, U.S. application Ser. No. 12/646,609 claims the benefit ofpriority from U.S. Provisional No. 61/140,725, filed on Dec. 24, 2008,which is hereby incorporated by reference in its entirety herein.

BACKGROUND

1. Field of the Invention

The present invention relates to ultrasound therapy systems, and inparticular to methods and systems for treating cellulite or reducingfat.

2. Description of the Related Art

In general, cellulite refers to a common skin disorder which ischaracterized by a dimple appearance in a person's skin that may befound on the hips, thighs, and/or buttocks. Underneath the dermis andepidermis layers of the skin there are multiple layers of fat. Cellulitetends to develop in the subcutaneous fat layers, which is unique ascompared to other fat layers because the subcutaneous fat can bestructured into specific chambers surrounded by strands of linkedtissue, which are known as fat lobuli. This appearance is much morecommon in women than in men because of differences in the way fat,muscle, and connective tissue are distributed in men's and women's skin.The lumpiness of cellulite is caused by the fat lobuli that push anddistort the connective tissues beneath the skin; resulting protrusionsand depressions of connective tissue anchor points create the appearanceof cellulite.

Invasive treatments for cellulite include Iontophoresis, liposuction,and electrolipophoresis, which can involve an application of alow-frequency electric current. Non-invasive treatments for cellulitecan include laser and suction massage combination therapy, pneumaticpressure massage therapy, lymphatic drainage massage, and low-frequencyultrasound diathermy. Such invasive and non-invasive treatments haveyielded marginal results. In addition, a number of drugs that act onfatty tissue have been tried as therapeutic agents for cellulitetreatment. Such drugs can be administered orally, applied topically asointments, or by trans-dermal injection. At this point, no drug has beenreported in the scientific literature as having a significant effect oncellulite. New developments for the treatment of cellulite are needed.

In addition, similar techniques have attempted to address the reductionof fat in humans, but such attempts have likewise had mixed results.

SUMMARY

In accordance with various aspects of the present invention,non-invasive methods and systems for fat reduction and/or treatment ofcellulite are provided. In accordance with an exemplary embodiment, anon-invasive method for cellulite treatment can include targeting aregion of interest below a surface of skin, which contains fat lobuliand delivering ultrasound energy to the region of interest. Theultrasound energy generates a conformal lesion with said ultrasoundenergy on a surface of a fat lobuli. The lesion creates an opening inthe surface of the fat lobuli, which allows the draining of a fluid outof the fat lobuli and through the opening.

In accordance with an exemplary embodiment, a non-invasive method forcellulite treatment can include targeting fat cells in a subcutaneousfat layer and delivering ultrasound energy to raise the temperature ofthe fat cells, stimulating apoptosis of the fat cells and then allowingthe targeted fat cells to die, thereby reducing a quantity of fat cellsin the subcutaneous layer.

Further areas of applicability will become apparent from the descriptionprovided herein. It should be understood that the description andspecific examples are intended for purposes of illustration only and arenot intended to limit the scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.The present invention will become more fully understood from thedetailed description and the accompanying drawings wherein:

FIG. 1 illustrates a block diagram of an ultrasound treatment system fortreating cellulite in accordance with exemplary embodiments of thepresent invention;

FIG. 2 illustrates a cross-sectional diagram of a transducer system inaccordance with exemplary embodiments of the present invention;

FIGS. 3A and 3B illustrate block diagrams of an exemplary control systemin accordance with exemplary embodiments of the present invention;

FIGS. 4A and 4B illustrate block diagrams of an exemplary probe systemin accordance with exemplary embodiments of the present invention;

FIG. 5 illustrates a cross-sectional diagram of an exemplary transducerin accordance with exemplary embodiments of the present invention;

FIGS. 6A and 6B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with exemplary embodiments of the presentinvention;

FIG. 7 illustrates exemplary transducer configurations for ultrasoundtreatment in accordance with exemplary embodiments of the presentinvention;

FIGS. 8A and 8B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with exemplary embodiments of the presentinvention;

FIG. 9 illustrates an exemplary transducer configured as atwo-dimensional array for ultrasound treatment in accordance withexemplary embodiments of the present invention;

FIGS. 10A-10F illustrate cross-sectional diagrams of exemplarytransducers in accordance with exemplary embodiments of the presentinvention;

FIG. 11 illustrates a schematic diagram of an acoustic coupling andcooling system in accordance with exemplary embodiments of the presentinvention;

FIG. 12 illustrates a block diagram of a treatment system comprising anultrasound treatment subsystem combined with additional subsystems andmethods of treatment monitoring and/or treatment imaging as well as asecondary treatment subsystem in accordance with exemplary embodimentsof the present invention;

FIG. 13 is a cross-sectional diagram illustrating a method of treatingcellulite in accordance with exemplary embodiments of the presentinvention;

FIGS. 14A and 14B are cross-sectional diagrams illustrating anothermethod of treating cellulite in accordance with exemplary embodiments ofthe present invention;

FIG. 15 is a block diagram illustrating a method of treating cellulitein accordance with exemplary embodiments of the present invention;

FIGS. 16A and 16B are cross-sectional diagrams illustrating a method ofreducing fat and treating cellulite in accordance with exemplaryembodiments of the present invention;

FIG. 17 is a block diagram illustrating a method of fat reduction inaccordance with exemplary embodiments of the present invention; and

FIGS. 18A and 18B are cross-sectional diagrams illustrating a method ofreducing fat in accordance with exemplary embodiments of the presentinvention.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present invention or its teachings, applications,or uses thereof. It should be understood that throughout the drawings,corresponding reference numerals indicate like or corresponding partsand features. The description of specific examples indicated in variousembodiments and aspects of the present invention are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention disclosed herein. Moreover, recitation of multipleembodiments having stated features is not intended to exclude otherembodiments having additional features or other embodimentsincorporating different combinations of the stated features.

The present invention may be described herein in terms of variousfunctional components and processing steps. It should be appreciatedthat such components and steps may be realized by any number of hardwarecomponents configured to perform the specified functions. For example,the present invention may employ various medical treatment devices,visual imaging and display devices, input terminals and the like, whichmay carry out a variety of functions under the control of one or morecontrol systems or other control devices. In addition, the presentinvention may be practiced in any number of medical or cosmetic contextsand the exemplary embodiments relating to a non-invasive methods andsystems for fat reduction and/or cellulite treatment as described hereinare merely indicative of exemplary applications for the invention. Forexample, various of the principles, features and methods discussedherein may be applied to any medical or cosmetic application, or otherrelated applications.

Various aspects of the present invention provide a method ofnon-invasive treatment of cellulite. The method includes targeting aregion of interest below a surface of skin, which contains fat lobuliand delivering ultrasound energy to the region of interest. Theultrasound energy generates a conformal lesion within the ultrasoundenergy on a surface of a fat lobuli, such as, for example, by creating asharp focal of ultrasound energy onto the fat lobuli. The lesion createsan opening in the surface of the fat lobuli, such as, for example, bypiercing the fat lobuli, which allows the draining of a fluid out of thefat lobuli through the opening.

Various aspects of the present invention can also provide a method forfat reduction that can include heating a region of interest to atemperature in a range from about 43° C. to about 49° C., which canstimulate apoptosis of at least one fat cell in the fat lobuli. Stillfurther, the method can include applying a physical treatment to saidsurface of skin and such physical treatment can include mesotherapy,Iontophoresis, pressotherapy, pneumatic massage, lymphatic drainage,electrolipophoresis, roller massage, low frequency ultrasound, vacuumsuction, laser energy, and application of RF energy. The physicaltreatment can be before, after, or concurrent with the delivery of theultrasound energy. The method can include the use of a second energy,which can be used before, after, or concurrent with the delivery of theultrasound energy. The method can reduce the appearance of cellulite onthe surface of skin.

Various aspects of the present invention provide a method ofnon-invasively stimulating apoptosis of a fat cell located in asubcutaneous fat layer. The method include targeting at least one fatcell in a subcutaneous layer below a skin surface and delivering energyto the fat cell. The delivered energy raises a temperature of the fatcell into a range from about 43° C. to about 49° C., which stimulatesapoptosis of the fat cell.

The method can further include imaging of the fat cell. Still further,the method can include generating a conformal lesion into said at leastone fat cell, which can create an opening in the fat cell and allow themoving of a material out of the fat cell through the opening. The energyis typically ultrasound energy in the range of about 750 kHz to about 20MHz or in a range from about 2 MHz to about 20 MHz, or other morespecific ranges. Still further the method can include applying aphysical treatment to said surface of skin and such physical treatmentcan include mesotherapy, Iontophoresis, pressotherapy, pneumaticmassage, lymphatic drainage, electrolipophoresis, roller massage,low-frequency ultrasound, vacuum suction, laser energy, and applicationof RF energy. The physical treatment can be before, after, or concurrentwith the delivery of the energy. The method can include the use of asecond energy, which can be used before, after, or concurrent with thedelivery of the energy. The method can reduce the number of fat cells inthe subcutaneous fat layer.

In addition, various aspects of the present invention provide a methodthat combines fat reduction and cellulite reduction. The method includestargeting a region of interest below a surface of skin, which containsfat lobuli, and delivering ultrasound energy to the region of interest.The ultrasound energy generates a conformal lesion with said ultrasoundenergy on a surface of a fat lobuli. The lesion creates an opening inthe surface of the fat lobuli, which allows the draining of a fluid outof the fat lobuli through the opening. Additionally, the method caninclude targeting at least one fat cell in a subcutaneous layer below askin surface and delivering a second energy to the fat cell. Thedelivered second energy raises a temperature of the fat cell into arange from about 43° C. to about 49° C., which stimulates apoptosis ofthe fat cell.

The method can further include a physical treatment as described herein,as well as the use of a secondary energy source. The method can bothreduce the number of fat cells in the subcutaneous fat layer and reducethe appearance of cellulite on a skin surface. The method can beeffective in physically breaking fat cell clusters and stretchingfibrous bonds of cellulite.

In accordance with an exemplary embodiment, a method of non-invasivetreatment of cellulite can include targeting a region of interest belowa skin surface, which contains fat lobuli, and delivering ultrasoundenergy at a specified depth below the skin surface. The method furtherincludes moving a source of the energy along the skin surface andablating a portion of the fat lobuli at the specified depth below theskin surface.

In accordance with the exemplary method, a specified depth is generallyin the range of about 1 mm to about 35 mm below the skin surface. Themethod can include applying a physical treatment as described herein.The method can smooth the skin surface and may reduce the appearance ofcellulite on the skin surface. The method can further include any of theadditional method steps discussed herein.

In accordance with various aspects of the present invention,non-invasive methods and systems for the reduction of fat and/or thetreating of cellulite are provided. For example, in accordance with anexemplary embodiment, with reference to FIG. 1, an exemplary treatmentsystem 100 configured to treat a region of interest 106 comprises acontrol system 102, an imaging/therapy probe with acoustic coupling 104,and a display system 108.

Control system 102 and display system 108 can comprise variousconfigurations for controlling probe 104 and overall system 100functionality. In various embodiments, control system 102 can include,for example but not limited to any of the following, a microprocessorwith software and a plurality of input/output devices, systems ordevices for controlling electronic and/or mechanical scanning and/ormultiplexing of transducers, systems for power delivery, systems formonitoring, systems for sensing the spatial position of the probe and/ortransducers, and/or systems for handling user input and recordingtreatment results, among others. Imaging/therapy probe 104 can comprisevarious probe and/or transducer configurations. For example, probe 104can be configured for a combined dual-mode imaging/therapy transducer,coupled or co-housed imaging/therapy transducers, or simply a separatetherapy probe and an imaging probe.

In accordance with an exemplary embodiment, treatment system 100 isconfigured for treating a deep tissue region that contains a lower partof dermis and proximal protrusions of fat lobuli into the dermis by,first, imaging region of interest (“ROI”) 210 for localization of thetreatment area and surrounding structures, second, delivering ultrasoundenergy at a depth, distribution, timing, and energy level to achieve thedesired therapeutic effect, and third monitoring the treatment areabefore, during, and after therapy to plan and assess the results and/orprovide feedback. As to the delivery of energy, control system 102 andtransducer system 102 can be suitably configured to deliver conformalultrasound therapeutic energy to ROI 210 creating a thermal injury andcoagulating the proximal protrusions of fat lobuli, thereby eliminatingthe fat protrusions into the dermis. As used herein, the term “dermis”refers to any part of the dermis and/or the epidermis.

Because the location and thickness of the fat lobuli varies from onepatient to another (due to genetics, weight, age, etc.), imaging using atransducer can facilitate treatment within a patient, however imaging isnot required to treat cellulite.

By planning a treatment protocol, the user may choose one or morespatial and/or temporal characteristics to provide conformal ultrasoundenergy to ROI 210. For example, the user may select one or more spatialcharacteristics to control, including, for example, the use of one ormore transducers, one or more mechanical and/or electronic focusingmechanisms, one or more transduction elements, one or more placementlocations of the transducer relative to ROI 210, one or more feedbacksystems, one or more mechanical arms, one or more orientations of thetransducer, one or more temperatures of treatment, one or more couplingmechanisms and/or the like.

In addition, the user may choose one or more temporal characteristics tocontrol in order to facilitate treatment of ROI 210. For example, theuser may select and/or vary the treatment time, frequency, power,energy, amplitude and/or the like in order to facilitate temporalcontrol. For more information on selecting and controlling ultrasoundspatial and temporal characteristics, see U.S. application Ser. No.11/163,148, entitled “Method and System for Controlled Thermal Injury”,filed Oct. 6, 2005, published on Jun. 1, 2006 as U.S. Patent ApplicationPublication No. 20060116671, and incorporated herein by reference.

After planning of a treatment protocol is complete, the treatmentprotocol can be implemented. That is, a transducer system can be used todeliver ultrasound energy to a treatment region to ablate select tissuein order to facilitate cellulite treatment. By delivering energy, thetransducer may be driven at a select frequency, a phased array may bedriven with certain temporal and/or spatial distributions, a transducermay be configured with one or more transduction elements to providefocused, defocused and/or planar energy, and/or the transducer may beconfigured and/or driven in any other ways hereinafter devised.

For treatment of ROI 210, transducer system 102 may be configured todeliver one or more energy fields to promote one or more effects, forexample, ablation of existing tissue, the breaking up of fat cellclusters, stretching of the fibrous bonds, enhancement of lymphaticdrainage, stimulation of the evacuation of fat decay products, and/orenhanced cell permeability in order to treat cellulite. Additionally,for treatment of ROI 210, transducer system 102 may be configured todeliver one or more energy fields to promote one or more effects, forexample cell apoptosis, piercing cells to promote drainage, and ablatinga layer of fat cells to a specified distance below a skin surface, suchas for example giving the fat cells a haircut. Of course transducersystem may be configured to deliver one energy field as needed by any ofthe methods of treatment described herein. As described herein, imagingis not necessary for treatment methods or treatment plans but rather isan optional step. For example, the dimpled pattern of cellulite istypically visible on the surface of a patient's skin and the system usercan easily identify ROI 210 that will be treated.

Through operation of treatment system 100, a method for treatment ofcellulite can be realized that can facilitate effective and efficienttherapy without creating chronic injury to human tissue. For example, auser may first select one or more transducer probe configurations fortreating ROI 210. The user may select any probe configuration describedherein. Because the treatment region ranges from about 0 mm to greaterthan about 5.5 cm or from about 1 mm to about 3.5 cm, exemplarytransducer probes may include, for example, an annular array, a variabledepth transducer, a mechanically moveable transducer, acylindrical-shaped transducer, a linear or flat transducer and the like.As used herein, the term user may include a person, employee, doctor,nurse, and/or technician, utilizing any hardware and/or software ofother control systems.

Once one or more transducers are selected, the user may then image ROI210 in order to plan a treatment protocol. By imaging ROI 210, the usermay use the same treatment transducer probe and/or one or moreadditional transducers to image ROI 210 at a high resolution. In oneembodiment, the transducer may be configured to facilitate high speedimaging over a large ROI 210 to enable accurate imaging over a large ROI210. In another embodiment, ultrasound imaging may include, individuallyor in combination, the use of Doppler flow monitoring and/or color flowmonitoring. In addition, other means of imaging such as photography andother visual optical methods, MRI, X-Ray, PET, infrared or others can beutilized separately or in combination for imaging and feedback of thesuperficial tissue and the vascular tissue in ROI 210.

An exemplary ultrasound therapy system of FIG. 1 is further illustratedin an exemplary embodiment in FIG. 2. A therapy transducer system 200includes a transducer probe 202 connected to control system 204, anddisplay 206, in combination may provide therapy, imaging, and/ortemperature or other tissue parameters monitoring to ROI 210. Exemplarytransducer system 200 is configured for, first, imaging and display ofROI 210 for localization of the treatment area and surroundingstructures, second, delivery of focused, unfocused, or defocusedultrasound energy at a depth, distribution, timing, and energy level toachieve the desired therapeutic effect of thermal ablation to treatcellulite, and, third, to monitor the treatment area and surroundingstructures before, during, and after therapy to plan and assess theresults and/or provide feedback to control system 204 and/or anoperator.

Exemplary transducer probe 202 can be configured to be suitablycontrolled and/or operated in various manners. For example, transducerprobe 202 may be configured for use within an ultrasound treatmentsystem, an ultrasound imaging system and/or an ultrasound imaging,therapy, and/or treatment monitoring system, including motion controlsubsystems.

Control system 204 can be configured with one or more subsystems,processors, input devices, displays and/or the like. Display 206 may beconfigured to image and/or monitor ROI 210 and/or any particularsub-region within ROI 210. Display 206 can be configured fortwo-dimensional, three-dimensional, real-time, analog, digital and/orany other type of imaging. Exemplary embodiments of both control system204 and display 206 are described in greater detail herein.

ROI 210, can be comprised of superficial layer (epidermis/dermis)subcutaneous fat, lobuli, and muscle. Exemplary transducer system 200 isconfigured to provide cross-sectional two-dimensional imaging of theregion 207, displayed as an image 205, with a controlled thermal lesion209, confined approximately to proximal portion of fat lobuli and lowerportion of dermis.

Transducer system 200 can be configured with the ability to controllablyproduce conformal treatment areas in superficial human tissue within ROI210 through precise spatial and temporal control of acoustic energydeposition. In accordance with an exemplary embodiment, control system204 and transducer probe 202 can be suitably configured for spatialcontrol of the acoustic energy by controlling the manner of distributionof the acoustical energy. For example, spatial control may be realizedthrough selection of the type of one or more transducer configurationsinsonifying ROI 210, selection of the placement and location oftransducer probe 202 for delivery of acoustical energy relative to ROI210, e.g., transducer probe 202 configured for scanning over part orwhole of ROI 210 to deliver conformal ultrasound therapeutic energy tocreate a thermal injury, such as a lesion, and to coagulate the proximalprotrusions of fat lobuli, thereby eliminating the fat protrusions intothe dermis. Transducer probe 202 may also be configured for control ofother environment parameters, e.g., the temperature at the acousticcoupling interface can be controlled. In addition to the spatialcontrol, control system 204 and/or transducer probe 202 can also beconfigured for temporal control, such as through adjustment andoptimization of drive amplitude levels, frequency/waveform selections,and timing sequences and other energy drive characteristics to controlthe treatment of tissue. The spatial and/or temporal control can also befacilitated through open-loop and closed-loop feedback arrangements,such as through the monitoring of various positional and temporalcharacteristics. For example, through such spatial and/or temporalcontrol, an exemplary treatment system 200 can enable the regions ofthermal injury to possess arbitrary shape and size and allow the tissueto be treated in a controlled manner.

Transducer system 200 may be used to provide a mechanical action ofultrasound to physically break fat cell clusters and stretch the fibrousbonds. This mechanical action will also enhance lymphatic drainage,stimulating the evacuation of fat decay products. That is, theultrasound may facilitate movement of the muscles and soft tissueswithin ROI 210, thereby facilitating the loosening of fat depositsand/or the break up of fibrous tissue surrounding fat deposits.

In addition, transducer system 200 can be configured to deliver varioustherapeutic levels of ultrasound to increase the speed at which fatmetabolizes, according to Arrhenius' Law: K=Ae.sup.−B/T, where K is thekinetic rate of fat metabolization, A is a constant, B is the activationenergy, and T is the temperature in degrees Kelvin. According toArrhenius' Law, a metabolic reaction is a function of temperature. Inexemplary embodiments, transducer system 200 is configured to providevarious therapeutic levels of ultrasound to increase a temperature offat cells in order to maximize the speed at which fat metabolizes.Moreover, transducer system 200 can be configured to deliver varioustherapeutic levels of ultrasound to increase the speed at which fatmetabolizes. According to a modified equation of Arrhenius' Law, ametabolic reaction is a function of temperature and time, T:K=Ate.sup.−B/T, where K is the kinetic rate of fat metabolization, A isa constant, B is the activation energy, t is time, and T is thetemperature in degrees Kelvin. In exemplary embodiments, transducersystem 200 is configured to provide various therapeutic levels ofultrasound for a specified time period or for a pulsed delivery overtime to increase a temperature of fat cells in order to maximize thespeed at which fat metabolizes. Moreover, transducer system 200 can beconfigured to deliver various therapeutic levels of ultrasound for aspecified time period or for a pulsed delivery over time to increase thespeed at which fat metabolizes. Thus, ultrasound treatment fromtransducer system 200, ranging from approximately 750 kHz to 20 MHz, canincrease the temperature in a treatment area, thereby increasing themetabolic reaction yield for that treatment area. As such, fatmetabolism in the treatment area is increased which leads to fat cellreduction and decreases the appearance of cellulite above the treatmentarea. Ultrasound treatment from transducer 200 can be programmed toprovide appropriate temperatures and optionally for appropriate time toROI 210 to increase the spread of fat cell metabolism leading to fatcell destruction and optionally reducing the appearance of cellulite.

In some aspects of the present invention, a method of increasingmetabolism of fat cells in a subcutaneous fat layer is provided. Themethod can include targeting a plurality of fat cells in a subcutaneousfat layer, heating the plurality of fat cells to a temperature asdefined by Arrhenius' Law, increasing a metabolism of at least a portionof the plurality of fat cells, and reducing a portion of the pluralityof fat cells. The method can also include any physical treatmentdescribed herein before, after, and/or concurrent with increasing themetabolism of the fat cells. In addition, the method can include the usea secondary energy as described herein.

As previously described, control systems 104 and 204 may be configuredin a variety of manners with various subsystems and subcomponents. Withreference to FIGS. 3A and 3B, in accordance with exemplary embodiments,an exemplary control system 300 can be configured for coordination andcontrol of the entire therapeutic treatment process in accordance withthe adjustable settings made by a therapeutic treatment system user. Forexample, control system 300 can suitably comprise power sourcecomponents 302, sensing and monitoring components 304, cooling andcoupling controls 306, and/or processing and control logic components308. Control system 300 can be configured and optimized in a variety ofways with more or less subsystems and components to implement thetherapeutic system for cellulite treatment, and the embodiment in FIGS.3A and 3B are merely for illustration purposes.

For example, for power sourcing components 302, control system 300 cancomprise one or more direct current (DC) power supplies 303 configuredto provide electrical energy for entire control system 300, includingpower required by transducer electronic amplifier/driver 312. DC currentsense device 305 can also be provided to confirm the level of powergoing into amplifiers/drivers 312 for safety and monitoring purposes.

Amplifiers/drivers 312 can comprise multi-channel or single channelpower amplifiers and/or drivers. In accordance with an exemplaryembodiment for transducer array configurations, amplifiers/drivers 312can also be configured with a beamformer to facilitate array focusing.An exemplary beamformer can be electrically excited by anoscillator/digitally controlled waveform synthesizer 310 with relatedswitching logic.

Power sourcing components 302 can also include various filteringconfigurations 314. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 312 to increasethe drive efficiency and effectiveness. Power detection components 316may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 316may be used to monitor the amount of power going to an exemplary probesystem.

Various sensing and monitoring components 304 may also be suitablyimplemented within control system 300. For example, in accordance withan exemplary embodiment, monitoring, sensing and interface controlcomponents 324 may be configured to operate with various motiondetection systems implemented within transducer probe 104 to receive andprocess information such as acoustic or other spatial and temporalinformation from ROI 210. Sensing and monitoring components can alsoinclude various controls, interfacing and switches 309 and/or powerdetectors 316. Such sensing and monitoring components 304 can facilitateopen-loop and/or closed-loop feedback systems within treatment system100.

For example, in such an open-loop system, a system user can suitablymonitor the imaging and/or other spatial or temporal parameters and thenadjust or modify the same to accomplish a particular treatmentobjective. Instead of, or in combination with, open-loop feedbackconfigurations, an exemplary treatment system can comprise a closed-loopfeedback system, wherein images and/or spatial/temporal parameters canbe suitably monitored within monitoring components 304 to generatesignals.

During operation of exemplary treatment system 100, a lesionconfiguration of a selected size, shape, and orientation is determined.Based on that lesion configuration, one or more spatial parameters areselected, along with suitable temporal parameters, the combination ofwhich yields the desired conformal lesion. Operation of the transducercan then be initiated to provide the conformal lesion or lesions. Openand/or closed-loop feedback systems can also be implemented to monitorthe spatial and/or temporal characteristics, and/or other tissueparameter monitoring, to further control the conformal lesions.

Cooling/coupling control systems 306 may be provided to remove wasteheat from exemplary probe 104, provide a controlled temperature at thesuperficial tissue interface and deeper into tissue, and/or provideacoustic coupling from transducer probe 104 to ROI 210. Suchcooling/coupling control systems 306 can also be configured to operatein both open-loop and/or closed-loop feedback arrangements with variouscoupling and feedback components.

Processing and control logic components 308 can comprise various systemprocessors and digital control logic 307, such as one or more ofmicrocontrollers, microprocessors, field-programmable gate arrays(FPGAs), computer boards, and associated components, including firmwareand control software 326, which interfaces to user controls andinterfacing circuits as well as input/output circuits and systems forcommunications, displays, interfacing, storage, documentation, and otheruseful functions. System software and firmware 326 controls allinitialization, timing, level setting, monitoring, safety monitoring,and all other system functions required to accomplish user-definedtreatment objectives. Further, various control switches 308 can also besuitably configured to control operation.

An exemplary transducer probe 104 can also be configured in variousmanners and can comprise a number of reusable and/or disposablecomponents and parts in various embodiments to facilitate its operation.For example, transducer probe 104 can be configured within any type oftransducer probe housing or arrangement for facilitating the coupling ofa transducer to a tissue interface, with such housing comprising variousshapes, contours and configurations depending on the particulartreatment application. For example, in accordance with an exemplaryembodiment, transducer probe 104 can be depressed against a tissueinterface whereby blood perfusion is partially or wholly cut-off, andtissue is flattened in superficial treatment ROI 210. Transducer probe104 can comprise any type of matching, such as for example, electricmatching, which may be electrically switchable; multiplexer circuitsand/or aperture/element selection circuits; and/or probe identificationdevices, to certify probe handle, electric matching, transducer usagehistory and calibration, such as one or more serial EEPROM (memories).

Transducer probe 104 may also comprise cables and connectors; motionmechanisms, motion sensors and encoders; thermal monitoring sensors;and/or user control and status related switches, and indicators such asLEDs. For example, a motion mechanism in probe 104 may be used tocontrollably create multiple lesions, or sensing of probe motion itselfmay be used to controllably create multiple lesions and/or stop creationof lesions, e.g. for safety reasons if probe 104 is suddenly jerked oris dropped. In addition, an external motion encoder arm may be used tohold the probe during use, whereby the spatial position and attitude ofprobe 104 is sent to the control system to help controllably createlesions. Furthermore, other sensing functionality such as profilometersor other imaging modalities may be integrated into the probe inaccordance with various exemplary embodiments.

With reference to FIGS. 4A and 4B, in accordance with an exemplaryembodiment, transducer probe 400 can comprise control interface 402,transducer 404, coupling components 406, and monitoring/sensingcomponents 408, and/or motion mechanism 410. However, transducer probe400 can be configured and optimized in a variety of ways with more orless parts and components to provide ultrasound energy for cellulitetreatment and/or fat reduction, and the embodiments illustrated in FIGS.4A and 4B are merely for illustration purposes. In some embodiments,transducer probe 104 is equivalent to transducer probe 400. In someembodiments, transducer probe 104, discussed above, can comprise controlinterface 402, transducer 404, coupling components 406, andmonitoring/sensing components 408, and/or motion mechanism 410.

In accordance with an exemplary embodiment of the present invention,transducer probe 400 is configured to deliver energy over varyingtemporal and/or spatial distributions in order to provide energy effectsand initiate responses in ROI 210. These effects can include, forexample, thermal, cavitational, hydrodynamic, and resonance inducedtissue effects. For example, exemplary transducer probe 400 can beoperated under one or more frequency ranges to provide two or moreenergy effects and initiate one or more responses in ROI 210. Inaddition, transducer probe 400 can also be configured to deliver planar,defocused and/or focused energy to ROI 210 to provide two or more energyeffects and to initiate one or more reactions. These responses caninclude, for example, diathermy, hemostasis, revascularization,angiogenesis, growth of interconnective tissue, tissue reformation,ablation of existing tissue, protein synthesis, cell apoptosis, and/orenhanced cell permeability.

These and various other exemplary embodiments of systems and componentsfor such combined ultrasound treatment, effects and responses are morefully set forth in U.S. patent application Ser. No. 10/950,112, entitled“Method and System for Combined Ultrasound Treatment”, filed Sep. 24,2004, published on Apr. 6, 2006 as U.S. Patent Application PublicationNo. 20060074355, and incorporated herein by reference.

In addition, these and various other exemplary embodiments of systemsand components for such combined ultrasound treatment, effects andresponses are more fully set forth in U.S. Pat. No. 6,050,943, entitled“Imaging, Therapy, and Temperature Monitoring Ultrasonic System”, issuedApr. 18, 2000, and U.S. Pat. No. 6,500,121 entitled “Imaging, Therapy,and temperature Monitoring Ultrasonic System,” issued Dec. 31, 2002,both of which are incorporated herein by reference.

Control interface 402 is configured for interfacing with control system300 to facilitate control of transducer probe 400. Control interfacecomponents 402 can comprise multiplexer/aperture select 424, switchableelectric matching networks 426, serial EEPROMs and/or other processingcomponents and matching and probe usage information 430 and interfaceconnectors 432.

Coupling components 406 can comprise various devices to facilitatecoupling of transducer probe 400 to ROI 210. For example, couplingcomponents 406 can comprise cooling and acoustic coupling system 420configured for acoustic coupling of ultrasound energy and signals.Coupling system 420 with possible connections such as manifolds may beutilized to couple sound into ROI 210, control temperature at theinterface and deeper into tissue, provide liquid-filled lens focusing,and/or to remove transducer waste heat. Coupling system 420 mayfacilitate such coupling through use of various coupling mediums,including air and other gases, water and other fluids, gels, solids,and/or any combination thereof, or any other medium that allows forsignals to be transmitted between transducer active elements 412 and ROI210. In addition to providing a coupling function, in accordance with anexemplary embodiment, coupling system 420 can also be configured forproviding temperature control during the treatment application. Forexample, coupling system 420 can be configured for controlled cooling ofan interface surface or region between transducer probe 400 and ROI 210and beyond by suitably controlling the temperature of the couplingmedium. The suitable temperature for such coupling medium can beachieved in various manners, and utilize various feedback systems, suchas thermocouples, thermistors or any other device or system configuredfor temperature measurement of a coupling medium. Such controlledcooling can be configured to further facilitate spatial and/or thermalenergy control of transducer probe 400.

Monitoring and sensing components 408 can comprise various motion and/orposition sensors 416, temperature monitoring sensors 418, user controland feedback switches 414 and other like components for facilitatingcontrol by control system 300, e.g., to facilitate spatial and/ortemporal control through open-loop and closed-loop feedback arrangementsthat monitor various spatial and temporal characteristics.

Motion mechanism 410 can comprise manual operation, mechanicalarrangements, or some combination thereof. For example, motion mechanism422 can be suitably controlled by control system 300, such as throughthe use of accelerometers, encoders or other position/orientationdevices 416 to determine and enable movement and positions of transducerprobe 400. Linear, rotational or variable movement can be facilitated,e.g., those depending on the treatment application and tissue contoursurface.

Transducer 404 can comprise one or more transducers configured forproducing conformal lesions of thermal injury in superficial humantissue within ROI 210 through precise spatial and temporal control ofacoustic energy deposition. Transducer 404 can also comprise one or moretransduction elements and/or lenses 412. The transduction elements cancomprise a piezoelectrically active material, such as lead zirconantetitanate (PZT), or any other piezoelectrically active material, such asa piezoelectric ceramic, crystal, plastic, and/or composite materials,as well as lithium niobate, lead titanate, barium titanate, and/or leadmetaniobate. In addition to, or instead of, a piezoelectrically activematerial, transducer 404 can comprise any other materials configured forgenerating radiation and/or acoustical energy. Transducer 404 can alsocomprise one or more matching layers configured along with thetransduction element such as coupled to the piezoelectrically activematerial. Acoustic matching layers and/or damping may be employed asnecessary to achieve the desired electroacoustic response.

In accordance with an exemplary embodiment, the thickness of thetransduction element of transducer 404 can be configured to be uniform.That is, transduction element 412 can be configured to have a thicknessthat is substantially the same throughout. In accordance with anotherexemplary embodiment, the thickness of transduction element 412 can alsobe configured to be variable. For example, transduction element(s) 412of transducer 404 can be configured to have a first thickness selectedto provide a center operating frequency of a lower range, for examplefrom approximately 750 kHz to 5 MHz. Transduction element 404 can alsobe configured with a second thickness selected to provide a centeroperating frequency of a higher range, for example from approximately 5MHz to 20 MHz or more. Transducer 404 can be configured as a singlebroadband transducer excited with at least two or more frequencies toprovide an adequate output for generating a desired response. Transducer404 can also be configured as two or more individual transducers,wherein each transducer comprises one or more transduction element. Thethickness of the transduction elements can be configured to providecenter-operating frequencies in a desired treatment range. For example,transducer 404 can comprise a first transducer configured with a firsttransduction element having a thickness corresponding to a centerfrequency range of approximately 750 kHz to 5 MHz, and a secondtransducer configured with a second transduction element having athickness corresponding to a center frequency of approximately 5 MHz to20 MHz or more.

Transducer 404 may be composed of one or more individual transducers inany combination of focused, planar, or unfocused single-element,multi-element, or array transducers, including 1-D, 2-D, and annulararrays; linear, curvilinear, sector, or spherical arrays; spherically,cylindrically, and/or electronically focused, defocused, and/or lensedsources.

In accordance with another exemplary embodiment, transducer probe 400may be suitably configured to provide three-dimensional treatment. Forexample, to provide three-dimensional treatment of ROI 210, withreference again to FIG. 4, a three-dimensional system can comprisetransducer probe 400 configured with an adaptive algorithm, such as, forexample, one utilizing three-dimensional graphic software, contained ina control system, such as for example control system 300. The adaptivealgorithm is suitably configured to receive two-dimensional imaging,temperature monitoring and/or treatment information relating to ROI 210,process the received information, and then provide correspondingthree-dimensional imaging, temperature and/or treatment information.

In accordance with another aspect of the invention, transducer probe 400may be configured to provide one, two or three-dimensional treatmentapplications for focusing acoustic energy to one or more regions ofinterest. For example, as discussed above, transducer probe 400 can besuitably diced to form a one-dimensional array, e.g., a transducercomprising a single array of sub-transduction elements.

For example, with reference to an exemplary embodiment depicted in FIG.5, exemplary transducer 500 can be configured as an acoustic array 502to facilitate phase focusing. That is, transducer 500 can be configuredas an array of electronic apertures that may be operated by a variety ofphases via variable electronic time delays. By the term “operated,” theelectronic apertures of transducer 500 may be manipulated, driven, used,and/or configured to produce and/or deliver an energy beam correspondingto the phase variation caused by the electronic time delay. For example,these phase variations can be used to deliver defocused beams 508,planar beams 504, and/or focused beams 506, each of which may be used incombination to achieve different physiological effects in ROI 210.Transducer 500 may additionally comprise any software and/or otherhardware for generating, producing and or driving a phased aperturearray with one or more electronic time delays.

Transducer 500 can also be configured to provide focused treatment toone or more regions of interest using various frequencies. In order toprovide focused treatment, transducer 500 can be configured with one ormore variable depth devices to facilitate treatment. For example,transducer 500 may be configured with variable depth devices disclosedin commonly assigned U.S. patent application Ser. No. 10/944,500,entitled “System and Method for Variable Depth Ultrasound”, filed onSep. 16, 2004, published on Mar. 16, 2006, as U.S. Patent ApplicationPublication No. 20060058664, and incorporated herein by reference. Insome embodiments, transducer probe 104 or transducer probe 400 cancomprise transducer 500.

In addition, transducer 500 can also be configured to treat one or moreadditional ROI 210 through the enabling of sub-harmonics or pulse-echoimaging, as disclosed in commonly assigned U.S. patent application Ser.No. 10/944,499, entitled “Method and System for Ultrasound Treatmentwith a Multi-directional Transducer”, filed on Sep. 16, 2004, publishedon Mar. 16, 2006 as U.S. Patent Application Publication No. 20060058707,and incorporated herein by reference.

Moreover, any variety of mechanical lenses or variable focus lenses,e.g. liquid-filled lenses, may also be used to focus and/or defocus thesound field. For example, with reference to exemplary embodimentsdepicted in FIGS. 6A and 6B, transducer 600 may also be configured withan electronic focusing array 604 in combination with one or moretransduction elements 606 to facilitate increased flexibility intreating ROI 210. Array 604 may be configured in a manner similar totransducer 502. That is, array 604 can be configured as an array ofelectronic apertures that may be operated by a variety of phases viavariable electronic time delays, for example, T₁, T₂ . . . T_(j). By theterm “operated,” the electronic apertures of array 604 may bemanipulated, driven, used, and/or configured to produce and/or deliverenergy in a manner corresponding to the phase variation caused by theelectronic time delay. For example, these phase variations can be usedto deliver defocused beams, planar beams, and/or focused beams, each ofwhich may be used in combination to achieve different physiologicaleffects in ROI 210.

Transduction elements 606 may be configured to be concave, convex,and/or planar. For example, in an exemplary embodiment depicted in FIG.6A, transduction elements 606 are configured to be concave in order toprovide focused energy for treatment of ROI 210. Additional embodimentsof transducer 600 are disclosed in U.S. patent applications and U.S.patents that have been incorporated by reference herein.

In another exemplary embodiment, depicted in FIG. 6B, transductionelements 606 can be configured to be substantially flat in order toprovide substantially uniform energy to ROI 210. While FIGS. 6A and 6Bdepict exemplary embodiments with transduction elements 604 configuredas concave and substantially flat, respectively, transduction elements604 can be configured to be concave, convex, and/or substantially flat.In addition, transduction elements 604 can be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element can be configured to beconcave, while a second transduction element can be configured to besubstantially flat. In some embodiments, transducer probe 104 ortransducer probe 400 can comprise transducer 600.

To further illustrate the various structures for transducer 404, withreference to FIG. 7, ultrasound therapy transducer 700 can be configuredfor a single focus, an array of foci, a locus of foci, a line focus,and/or diffraction patterns. Transducer 700 can also comprise singleelements, multiple elements, annular arrays, one-, two-, orthree-dimensional arrays, broadband transducers, and/or combinationsthereof, with or without lenses, acoustic components, and mechanicaland/or electronic focusing. Transducers configured as sphericallyfocused single elements 702, annular arrays 704, annular arrays withdamped regions 706, line focused single elements 708, 1-D linear arrays710, 1-D curvilinear arrays in concave or convex form, with or withoutelevation focusing, 2-D arrays, and 3-D spatial arrangements oftransducers may be used to perform therapy and/or imaging and acousticmonitoring functions. For any transducer configuration, for example butnot limited to including those employed in transducer probe 104 ortransducer probe 400, focusing and/or defocusing may be in one plane ortwo planes via mechanical focus 720, convex lens 722, concave lens 724,compound or multiple lenses 726, planar form 728, or stepped form, suchas illustrated in FIG. 10F. Any transducer or combination of transducersmay be utilized for treatment. For example, an annular transducer may beused with an outer portion dedicated to therapy and the inner diskdedicated to broadband imaging wherein such imaging transducer andtherapy transducer have different acoustic lenses and design, such asillustrated in FIGS. 10C-10F, as described below.

With reference to FIGS. 8A and 8B, transducer 404 can be configured assingle-element arrays, wherein a single-element 802, e.g., atransduction element of various structures and materials, can beconfigured with a plurality of masks 804, such masks comprising ceramic,metal or any other material or structure for masking or altering energydistribution from element 802, creating an array of energy distributions808. Masks 804 can be coupled directly to element 802 or separated by astandoff 806, such as any suitably solid or liquid material.

In accordance with another exemplary embodiment, transducer probe 104 ortransducer probe 400 may be suitably diced in two dimensions to form atwo-dimensional array. For example, with reference to FIG. 9, anexemplary two-dimensional array 900 can be suitably diced into aplurality of two-dimensional portions 902. Two-dimensional portions 902can be suitably configured to focus on the treatment region at a certaindepth, and thus provide respective slices 904, 907 of the treatmentregion. As a result, the two-dimensional array 900 can provide atwo-dimensional slicing of image planes of a treatment region, thusproviding two-dimensional treatment.

In accordance with another exemplary embodiment, transducer probe 400may be suitably configured to provide three-dimensional treatment. Forexample, to provide three-dimensional treatment of ROI 210, withreference again to FIG. 3, a three-dimensional system can comprisetransducer probe 104 or transducer probe 400 configured with an adaptivealgorithm, such as, for example, one utilizing three-dimensional graphicsoftware, contained in a control system, such as for example controlsystem 300. The adaptive algorithm is suitably configured to receivetwo-dimensional imaging, temperature and/or treatment informationrelating to ROI 210, process the received information, and then providecorresponding three-dimensional imaging, temperature and/or treatmentinformation.

In accordance with an exemplary embodiment, with reference again to FIG.9, an exemplary three-dimensional system can comprise a two-dimensionalarray 900 configured with an adaptive algorithm to suitably receive 904slices from different image planes of the treatment region, process thereceived information, and then provide volumetric information 906, e.g.,three-dimensional imaging, temperature and/or treatment information.Moreover, after processing the received information with the adaptivealgorithm, the two-dimensional array 900 may suitably providetherapeutic heating to the volumetric region 906 as desired.

Alternatively, rather than utilizing an adaptive algorithm, such asthree-dimensional software, to provide three-dimensional imaging and/ortemperature information, an exemplary three-dimensional system cancomprise a single transducer 404 configured within a probe arrangementto operate from various rotational and/or translational positionsrelative to a target region.

An exemplary transducer 404 can also be configured as an annular arrayto provide planar, focused and/or defocused acoustical energy. Forexample, with reference to FIGS. 10A and 10B, in accordance with anexemplary embodiment, an annular array 1000 can comprise a plurality ofrings 1012, 1014, 1016 to N. Rings 1012, 1014, 1016 to N can bemechanically and electrically isolated into a set of individualelements, and can create planar, focused, or defocused waves. Forexample, such waves can be centered on-axis, such as by methods ofadjusting corresponding transmit and/or receive delays, T₁, T₂, T₃, . .. T_(N). An electronic focus can be suitably moved along various depthpositions, and can enable variable strength or beam tightness, while anelectronic defocus can have varying amounts of defocusing. In accordancewith an exemplary embodiment, a lens and/or convex or concave shapedannular array 1000 can also be provided to aid focusing or defocusingsuch that at any time differential delays can be reduced. Movement ofannular array 1000 in one, two or three-dimensions, or along any path,such as through use of probes and/or any conventional robotic armmechanisms, may be implemented to scan and/or treat a volume or anycorresponding space within ROI 210.

Transducer 404 can also be configured in other annular or non-arrayconfigurations for imaging/therapy functions. For example, withreference to FIGS. 10C-10F, a transducer can comprise an imaging element1012 configured with therapy element(s) 1014. Elements 1012 and 1014 cancomprise a single-transduction element, e.g., a combinedimaging/transducer element, or separate elements, can be electricallyisolated 1022 within the same transduction element or between separateimaging and therapy elements, and/or can comprise standoff 1024 or othermatching layers, or any combination thereof. For example, withparticular reference to FIG. 10F, a transducer can comprise an imagingelement 1012 having a surface 1028 configured for focusing, defocusingor planar energy distribution, with therapy elements 1014 including astepped-configuration lens configured for focusing, defocusing, orplanar energy distribution.

Various shaped treatment lesions can be produced using the variousacoustic lenses and designs in FIGS. 10A-10F. For example,mushroom-shaped lesions may be produced from a spherically-focusedsource, and/or planar lesions from a flat source. That is, as theapplication of ablative ultrasound energy continues, this causes thermalexpansion to generate a growing lesion. Concave planar sources andarrays can produce a “V-shaped” or ellipsoidal lesion. Electronicarrays, such as a linear array, can produce defocused, planar, orfocused acoustic beams that may be employed to form a wide variety ofadditional lesion shapes at various depths. An array may be employedalone or in conjunction with one or more planar or focused transducers.Such transducers and arrays in combination produce a very wide range ofacoustic fields and their associated benefits. A fixed focus and/orvariable focus lens or lenses may be used to further increase treatmentflexibility. A convex-shaped lens, with acoustic velocity less than thatof superficial tissue, may be utilized, such as a liquid-filled lens,gel-filled or solid gel lens, rubber or composite lens, with adequatepower handling capacity; or a concave-shaped, low profile, lens may beutilized and composed of any material or composite with velocity greaterthan that of tissue. While the structure of transducer source andconfiguration can facilitate a particular shaped lesion as suggestedabove, such structures are not limited to those particular shapes as theother spatial parameters, as well as the temporal parameters, canfacilitate additional shapes within any transducer structure and source.

In accordance with an exemplary embodiment, with additional reference toFIG. 11, acoustic coupling and cooling 1140 can be provided toacoustically couple energy and imaging signals from transducer probe1104 to and from ROI 210, to provide thermal control at the probe to ROI210 interface 1110, and to remove potential waste heat from thetransducer probe at region 1144. Temperature monitoring can be providedat the coupling interface via thermal sensor 1146 to provide a mechanismof temperature measurement 1148 and control via control system 1106 andthermal control system 1142. Thermal control may consist of passivecooling such as via heat sinks or natural conduction and convection orvia active cooling such as with pettier thermoelectric coolers,refrigerants, or fluid-based systems comprised of pump, fluid reservoir,bubble detection, flow sensor, flow channels/tubing 1144 and thermalcontrol 1142. In some embodiments, transducer probe 1104 can beequivalent to transducer probe 104 or transducer probe 400.

In accordance with another exemplary embodiment, with reference to FIG.12, an exemplary treatment system 200 can be configured with and/orcombined with various auxiliary systems to provide additional functions.For example, an exemplary treatment system 1200 for treating ROI 210 cancomprise a control system 1206, a probe 1204, and a display 1208. Insome embodiments, probe 1204 can be equivalent to transducer probe 104or transducer probe 400 or transducer probe 1104. Treatment system 1200further comprises an auxiliary imaging modality 1274 and/or auxiliarymonitoring modality 1272 may be based upon at least one of photographyand other visual optical methods, magnetic resonance imaging (MRI),computed tomography (CT), optical coherence tomography (OCT),electromagnetic, microwave, or radio frequency (RF) methods, positronemission tomography (PET), infrared, ultrasound, acoustic, or any othersuitable method of visualization, localization, or monitoring ofcellulite within ROI 210, including imaging/monitoring enhancements.Such imaging/monitoring enhancement for ultrasound imaging via probe1204 and control system 1206 could comprise M-mode, persistence,filtering, color, Doppler, and harmonic imaging among others;furthermore an ultrasound treatment system 1270, as a primary source oftreatment, may be combined with a secondary source of treatment 1276,including radio frequency (RF), intense pulsed light (IPL), laser,infrared laser, microwave, or any other suitable energy source.

An ultrasound treatment system as described herein, as a primary sourceof treatment, may be combined with a secondary source of treatmentconfigured to deliver secondary treatment energy. Secondary treatmentenergy includes, but is not limited to, radio frequency (RF) energy,microwave energy, infrared light, visible light, ultraviolet light, andany other suitable electromagnetic energy. Secondary treatment energymay be coherent (as in a laser), incoherent, scattered, pulsed,refracted, focused, defocused, and/or delivered in any other formsuitable for achieving a bio-effect.

In an exemplary embodiment, ultrasound treatment is combined with bluelight treatment. As used herein, “blue light” means electromagneticenergy having a wavelength from about 400 nanometers to about 440nanometers. Blue light is applied to the skin. Blue light may be appliedas a pretreatment before therapeutic ultrasound energy is applied. Bluelight may also be applied concurrently with therapeutic ultrasoundenergy. Furthermore, blue light may be applied before, during, or aftertherapeutic ultrasound treatment, or during any combination thereof.

In accordance with an exemplary embodiment, blue light is applied to ROI210 for a period between 5 seconds and 20 minutes. Blue light may beapplied to ROI 210 for any suitable amount of time in order to achieve adesired bio-effect.

In another exemplary embodiment, ultrasound treatment is combined withred light treatment. As used herein, “red light” means electromagneticenergy having a wavelength from about 600 nanometers to about 1350nanometers. Red light is applied to ROI 210. Red light may be applied asa pretreatment before therapeutic ultrasound energy is applied. Redlight may also be applied concurrently with therapeutic ultrasoundenergy. Furthermore, red light may be applied before, during, or aftertherapeutic ultrasound treatment, or during any combination thereof.

In accordance with an exemplary embodiment, red light is applied to theskin for a period between 5 seconds and 20 minutes. Red light may beapplied to the skin for any suitable amount of time in order to achievea desired bio-effect.

In accordance with an exemplary embodiment, secondary treatment energycan be delivered by the probe which contains an ultrasound energysource. In other exemplary embodiments, secondary treatment energy isdelivered by a source external to the probe. Secondary treatment energymay be generated by a light emitting diode (LED), a laser, anincandescent bulb, a fluorescent tube, an antenna, an intense pulsedlight source, or any other suitable electromagnetic energy generationmechanism.

In one exemplary embodiment, energy is delivered in relatively smallablative areas in order to minimize and/or prevent scar tissue fromforming. That is, each ablative area of treatment can range fromapproximately 100 microns to 55 mm in diameter. In another exemplaryembodiment, ultrasound energy is used in a “lawnmower” type fashion toevenly ablate a treatment region to provide a substantially planarsurface of lobuli. This “lawnmower”-type ablation in turn, helps toachieve a substantially smooth surface of the epidermis.

With reference to FIG. 13, another method of non-invasive treatment ofcellulite is illustrated according to various other embodiments of thepresent invention. The cross-sectional diagram illustrates the layers oftissue below skin surface 1304 which is not to scale and is used forillustration purposes. Dermis layer 1302 includes skin surface 1304 andboth the epidermis and dermis portions of the skin. Below the dermislayer 1302 is fat lobuli 1307. Fat lobuli 1307 causes protrusions inskin surface 1304, which gives skin surface 1304 a dimpled appearance1311 or cellulite. Below fat lobuli 1307 is facia layer 1315,subcutaneous fat layer 1317 and then muscle layer 1319.

In various aspects, probe 202 is coupled to skin surface 1304 and emitsultrasound energy to create conformal lesion 209 at specific depth 1305.Conformal lesion 209 ablates a portion of fat lobuli 1307. Probemovement 1303 along skin surface 1304 allows for ablation of a pluralityof fat lobuli 1307 at specific depth 1305. This may be described as alawnmower type ablation or a haircut of fat lobuli 1307. Probe movement1303 leaves behind smoothed skin 1309. The treatment may need to berepeated in order to achieve a desired degree of smoothed skin 1309.This method may be combined with any other method steps described hereinsuch as for example applying a physical treatment or applying asecondary energy source.

In accordance with an exemplary embodiment of the present invention, amethod of non-invasive treatment of cellulite includes targeting ROI 210below skin surface 1304, which contains fat lobuli 1307, and deliveringultrasound energy at specified depth 1305 below skin surface 1304. Themethod further includes moving a source of the energy along skin surface1304 and ablating a portion of fat lobuli 1307 at specified depth 1305below skin surface 1304.

Specified depth 1305 is generally in the range of about 1 mm to about 35mm below skin surface 1304. The method can include applying a physicaltreatment as described herein. The method can smooth skin surface 1304and may reduce the appearance of cellulite on skin surface 1304. Themethod can further include any of the additional method steps discussedherein.

With reference to FIG. 14, a method of non-invasive treatment ofcellulite is illustrated according to another exemplary embodiment ofthe present invention. The cross-sectional diagram illustrates thelayers of tissue below skin surface 1304 which is not to scale and isused for illustration purposes. Dermis layer 1302 includes skin surface1304 and both the epidermis and dermis portions of the skin. Belowdermis layer 1302 is fat lobuli 1307. Fat lobuli 1307 causes protrusionsin skin surface 1304, which gives skin surface 1304 a dimpled appearance1311 or cellulite. Below fat lobuli 1307 is facia layer 1315,subcutaneous fat layer 1317 and then muscle layer 1319.

In the exemplary embodiment illustrated in FIG. 14A, probe 202 iscoupled to skin surface 1304 and emits ultrasound energy to createconformal lesion 209 in the surface of fat lobuli 1307 to create opening1321. A material that is housed in the punctured fat lobuli 1317 flowsout of opening 1321. This material can be a fluid, a lipid, a lyphomaticsubstance, fat, tissue, bodily materials, or any other material andmixtures thereof. The material can be any tissue, fluid, or the likethat is typically housed in fat lobuli 1317. Moving to FIG. 14B, reducedfat lobuli 1325 has shriveled due to the loss of the material. Theshrinking of reduced fat lobuli 1325 can cause smoothed skin 1309 abovereduced fat lobuli 1325 which has been drained of the material, therebyreducing the appearance of cellulite on skin surface 1304.

In accordance with another exemplary embodiment, a method ofnon-invasive treatment of cellulite includes targeting ROI 210 belowskin surface 1304, which contains fat lobuli 1307 and deliveringultrasound energy to ROI 210. The ultrasound energy generates conformallesion 209 with the ultrasound energy on a surface of fat lobuli 1307.The lesion creates opening 1321 in the surface of fat lobuli 1307, whichallows the draining of a fluid out of fat lobuli 1307 and throughopening 1321.

The method can further include heating ROI 210 to a temperature in arange from about 43° C. to about 49° C., which can stimulate apoptosisof at least one fat cell in fat lobuli 1307. Still further the methodcan include applying a physical treatment to skin surface 1304 and suchphysical treatment can include mesotherapy, Iontophoresis,pressotherapy, pneumatic massage, lymphatic drainage,electrolipophoresis, roller massage, low frequency ultrasound, vacuumsuction, laser energy, and/or an application of RF energy. The physicaltreatment can be before, after, or concurrent with the delivery of theultrasound energy. The method can include the use of a second energy,which can be used before, after, or concurrent with the delivery of theultrasound energy. The method can reduce the appearance of cellulite onskin surface 1304.

With additional reference to FIG. 15, a block diagram illustrates anexemplary method for non-invasive treatment of cellulite according tovarious embodiments of the present invention. For example, method 1500is a non-invasive treatment of cellulite. In step 1502, fat lobuli 1307is targeted. Imaging the fat lobuli in a step 1503 may be useful in thetargeting of fat lobuli 1307 but is optional or otherwise not required.

Targeting step 1502 is followed by energy delivery step 1504 whichdelivers ultrasound energy to form a conformal lesion 209 in the targetwhich can be for example fat lobuli 1307. The ultrasound energy can bein the range from about 750 kHz to about 20 MHz and may be more usefulin the range from about 2 MHz to about 10 MHz. The power of theultrasound energy may be in a range from about 1 W to about 50 W and maybe more useful in the range from about 2 W to about 20 W. The durationof the ultrasound energy may be in the range from about 10 millisecondsto about 20 minutes, or even more if desired. Energy delivery step 1504may include applying secondary energy step 1505, which is optional.Applying a secondary energy step 1505 may be useful in heating thetissue around the target to an elevated temperature prior to or duringdelivery of ultrasound energy to the targeted region, and can comprise avariety of energy sources including those discussed previously herein.

Energy delivery step 1504 is followed by creating an opening in thetarget step 1506, which provides an opening 1321. In this step 1506,conformal lesion 209 creates opening 1321 in the target. Upon creatingan opening in the target, step 1506 is followed by a release of contentsstep 1508, in which at least a portion of the contents of fat lobuli1307 are released through opening 1321, e.g., by draining. Anapplication of secondary energy step 1505 may be applied after thecreation of opening 1321 but is optional. Such application of secondaryenergy step 1505 may be useful in smoothing skin surface 1304 and/or infacilitating movement of at least a portion of the contents of fatlobuli 1307 to facilitate their release. The contents of fat lobuli 1307can be a fluid, a lipid, a lyphomatic substance, fat, tissue, bodilymaterials, or any other material and mixtures thereof. An application ofphysical treatment step 1507, such as, for example, by applying physicalpressure or force to facilitate movement, may be useful in facilitatingthe releasing of at least a portion of the contents of fat lobuli 1307through opening 1321, but this step 1507 is optional. An optionalimaging step 1509 can be added for reviewing if the treatment wassuccessful. If the treatment complete decision 1511 is yes, then theresult is the final step 1510 wherein the skin is smoothed. If thetreatment complete decision 1511 is no, then move to step 1504 forfurther treatment of the target until the treatment is successful withinthe treatment area, resulting in the smoothing of skin step 1510 whichreduces the appearance of cellulite on skin surface 1304.

In accordance with another exemplary embodiment, a method ofnon-invasive treatment of cellulite includes identifying fat lobuli 1307and creating a sharp focal of ultrasound energy onto fat lobuli 1307.The focal of energy pierces fat lobuli 1307 to create opening 1321,which then allows the flowing of a material out of fat lobuli 1307through opening 1321. The method can further include any of theadditional method steps discussed herein.

Now referring to FIG. 16, a method of non-invasive treatment for areduction of fat is illustrated according to another exemplaryembodiment of the present invention. In various embodiments, this methodcan be used as a non-invasive treatment of cellulite. Thecross-sectional diagram illustrates the layers of tissue below skinsurface 1304 which is not to scale and is used for illustrationpurposes. Dermis layer 1302 includes skin surface 1304 and both theepidermis and dermis portions of the skin. Below dermis layer 1302 isfat lobuli 1307. Fat lobuli 1307 causes protrusions in skin surface1304, which gives skin surface 1304 a dimpled appearance 1311 orcellulite. Below fat lobuli 1307 is facia layer 1315, subcutaneous fatlayer 1317 and then muscle layer 1319.

In an exemplary embodiment, as illustrated in FIG. 16A, probe 202 iscoupled to skin surface 1304 and emits ultrasound energy into adiposetarget area 1331. Adipose target area 1331 can include a portion of fatlobuli 1307. Adipose target area 1331 can include ROI 210. Fat lobuli1307 can contain a plurality of adipose cells and a portion of theplurality of adipose cells can be located in adipose target area 1331.Adipose target area 1331 can include a plurality of other adipose cells1329 that may be amongst fat lobuli 1307.

Probe 202 is targeted to deliver energy in adipose target area 1331.Adipose target area 1331 can be from about 1 mm to about 100 mm orgreater below skin surface 1304. Height 1333 of adipose target area 1331can be from about 1 mm to about 10 mm or greater. Probe 202 deliversenergy to create at least one conformal lesion 209 in adipose targetarea 1331. Delivered energy raises a temperature of at least a portionof adipose cells in fat lobuli 1307 and/or other adipose cells 1329located in adipose target area 1331 to a range from about 43° C. toabout 49° C., which stimulates apoptosis of fat cells, which can includeat least a portion of other adipose cells in fat lobuli 1307 and/orother adipose cells 1329.

As illustrated in FIG. 16B, over a period of time, the portion of theplurality of adipose cells fat lobuli 1307 that were located in adiposetarget zone 1331 begin cell apoptosis. As these adipose cells die, fatlobuli 1307 shrinks. This cell apoptosis of the adipose cells reducesthe amount of fat in an area on a patient. The effect of the reductionin size of fat lobuli 1307 by the adipose cell apoptosis can createsmoothed skin 1309. In addition, other adipose cells 1329 that werelocated in adipose target area 1331 can begin cell apoptosis. As theseother adipose cells 1329 die, skin surface 1304 can relax, which cancontribute to creating smoothed skin 1309. Probe 202 can be moved alongskin surface 1304 to enlarge the treatment of adipose target area 1331of a patient's body.

An exemplary method, such as that illustrated by FIG. 16, can includeapplying a physical treatment to skin surface 1304, and such physicaltreatment can include mesotherapy, Iontophoresis, pressotherapy,pneumatic massage, lymphatic drainage, electrolipophoresis, rollermassage, low frequency ultrasound, vacuum suction, laser energy, andapplication of RF energy. The physical treatment can be before, after,or concurrent with the delivery of the energy. The method can includethe use of a second energy, which can be used before, after, orconcurrent with the delivery of the energy.

With reference to FIG. 17, a block diagram illustrates a method 1600 offat reduction according to an exemplary embodiment. For example, themethod 1600 begins with step 1602 which is the targeting of a group offat cells in adipose target area 1331. This targeting step 1602 mayinclude the movement of probe 202 to include an enlarged target area. Intargeting step 1602 a depth below skin surface 1304 that is appropriatefor adipose target area 1331 is determined. Generally, a depth ofgreater that 1 mm but less than 100 mm is appropriate and this can varyfrom patient to patient depending on location on the body and level ofpatient's body fat.

Targeting step 1602 is followed by energy delivery step 1603 which isthe delivering of ultrasound energy to the target fat cells. Theultrasound energy can be in the range from about 750 kHz to about 20 MHzand may be more useful in the range from about 2 MHz to about 10 MHz.The power of the ultrasound energy may be in a range from about 1 W toabout 50 W and may be more useful in the range from about 2 W to about20 W. The duration of the ultrasound energy may be in the range fromabout 10 milliseconds to about 20 minutes, or more if desired.

Energy delivery step 1603 is followed by raising temperature step 1604,which is the raising of the fat cell temperature from about 43.5° C. toabout 49° C. Different combinations of parameters outlined in energydelivery step 1603 can be useful to raise the fat cell temperature tothe desired range in step 1604. Raising temperature step 1604 creates orfacilitates the stimulating apoptosis step 1605 which is the stimulatingcell apoptosis of the fat cells in adipose target area 1331. If the fatcells are held in the desired temperature range for a sufficient amountof time, cell apoptosis will occur. Stimulating apoptosis step 1605 isfollowed by step 1606 which is the allowing of the targeted fat cellsand/or targeted portions thereof to die. Upon allowing target portionsto die in step 1606 results, a reduction of the total number of fatcells in adipose target area 1331 is achieved 1607. This reduction ofthe total number of fat cells can result in lowering the circumferenceof a patient's body, for example the circumference of thighs, buttocks,hips, waist, and the like. In addition, this reduction of adipose targetarea 1331 can reduce an appearance of cellulite on skin surface 1304.Alternatively, or simultaneously, method 1600 can target fat cells inthe subcutaneous fat layers to provide similar results.

Now with reference to FIGS. 18A and 18B, a method of non-invasivetreatment for a reduction of fat is illustrated according to variousexemplary embodiments of the present invention. In various embodiments,this method can be used as a non-invasive treatment of subcutaneous fatlayer 1317. The cross-sectional diagram illustrates the layers of tissuebelow skin surface 1304 which is not to scale and is used forillustration purposes. The dermis layer 1302 includes skin surface 1304and both the epidermis and dermis portions of the skin. Below dermislayer 1302 is fat lobuli 1307. Fat lobuli 1307 causes protrusions inskin surface 1304, which gives skin surface 1304 a dimpled appearance1311 or cellulite. Below fat lobuli 1307 is facia layer 1315,subcutaneous fat layer 1317 and then muscle layer 1319. Subcutaneous fatlayer 1317 can have a selected depth 1337.

In an exemplary embodiment as illustrated in FIG. 18A, probe 202 iscoupled to skin surface 1304 and emits ultrasound energy into adiposetarget area 1331. Adipose target area 1331 can include a portion ofsubcutaneous fat layer 1317. Subcutaneous fat layer 1317 can contain aplurality of adipose cells and a portion of the plurality of adiposecells can be located in adipose target area 1331.

Probe 202 is targeted to deliver energy in adipose target area 1331.Adipose target area 1331 can be from about 1 mm to about 100 mm orgreater below the surface of the skin 1304. Height 1333 of adiposetarget area 1331 can be from about 1 mm to about 10 mm or greater. Probe202 delivers energy to create at least one conformal lesion 209 which islocated in adipose target area 1331. Delivered energy raises atemperature of at least a portion of the adipose cells located inadipose target area 1331 in to a range from about 43° C. to about 49°C., which stimulates apoptosis of the fat cells, which can include atleast a portion of adipose cells in fat lobuli 1307 and/or other adiposecells 1399.

Over a period of time, the portion of the plurality of adipose cells insubcutaneous fat layer 1317 that were located in adipose target area1331 begin cell apoptosis. As these adipose cells die, subcutaneous fatlayer 1317 shrinks. This cell apoptosis of the adipose cells reduces theamount of fat in an area on a patient. As illustrated in FIG. 18B, theeffect of the adipose cell apoptosis in subcutaneous fat layer 1317 cancreate smoothed skin 1309.

In addition, the effect of the adipose cell apoptosis in subcutaneousfat layer 1317 can create a reduction 1335 in the total volume of tissuein the treatment area. In accordance with the method, probe 202 can bemoved along skin surface 1304 to enlarge the treatment of adipose targetarea 1331 of a patient's body. For example, this reduction 1335 cancause a decrease in the circumference of a patient's thighs, buttocks,hips, waist, and the like. As the adipose cell apoptosis in subcutaneousfat layer 1317 continues, skin surface 1304 can relax and can contributeto creating smoothed skin 1309. Subcutaneous fat layer 1317 can have areduced depth 1339 after cell apoptosis. Reduced cell depth 1339generally results from thickness of depth 1337 less the thickness 1333of adipose target area 1331, i.e., the portion shrunk from cellapoptosis.

Various exemplary methods as illustrated in FIG. 18 provide a method ofnon-invasively stimulating apoptosis of a fat cell located insubcutaneous fat layer 1317. The method includes targeting at least onefat cell in subcutaneous fat layer 1317 below skin surface 1304 anddelivering energy to the fat cell. The delivered energy raises atemperature of the fat cell into a range from about 43° C. to about 49°C., which stimulates apoptosis of the fat cell.

The method can further include imaging of a fat cell or fat lobuli 1307.Still further, the method can include generating conformal lesion 209into at least one fat cell, which can create opening 1321 in a fat cellor fat lobuli 1307 and allow the moving of a material out of a fat cellor fat lobuli 1307 and through opening 1321. This material can be afluid, a lipid, a lyphomatic substance, fat, tissue, bodily materials,or any other material and mixtures thereof. The ultrasound energy can bein the range from about 750 kHz to about 20 MHz and may be more usefulin the range from about 2 MHz to about 10 MHz. The power of theultrasound energy may be in a range from about 1 W to about 50 W and maybe more useful in the range from about 2 W to about 20 W. The durationof the ultrasound energy may be in the range from about 10 millisecondsto about 20 minutes. Still further, the method can include applying aphysical treatment to skin surface 1304 and such physical treatment caninclude mesotherapy, Iontophoresis, pressotherapy, pneumatic massage,lymphatic drainage, electrolipophoresis, roller massage, low frequencyultrasound, vacuum suction, laser energy, and application of RF energy.The physical treatment can be before, after, or concurrent with thedelivery of the energy. The method can include the use of a secondenergy, which can be used before, after, or concurrent with the deliveryof the energy. The method can reduce the number of fat cells insubcutaneous fat layer 1317.

In addition, various other exemplary embodiments of the presentinvention can include a method that combines fat reduction and cellulitereduction. The method includes targeting ROI 210 below skin surface1304, which contains fat lobuli 1307 and delivering ultrasound energy toROI 210. The ultrasound energy generates conformal lesion 209 with saidultrasound energy on a surface of fat lobuli 1307. Conformal lesion 209creates opening 1321 in the surface of fat lobuli 1307, which allows thedraining of a fluid out of fat lobuli 1307 and through opening 1321.Additionally, the method can include targeting at least one fat cell insubcutaneous fat layer 1321 below skin surface 1304 and delivering asecond energy to the fat cell. The delivered second energy raises atemperature of the fat cell into a range from about 43° C. to about 49°C., which stimulates apoptosis of the fat cell.

The method can further include a physical treatment as described herein,as well as the use of a secondary energy source. The method can bothreduce the number of fat cells in subcutaneous fat layer 1317 and reducethe appearance of cellulite on skin surface 1304. The method can beeffective in the physically breaking fat cell clusters and stretchingfibrous bonds of cellulite.

In accordance with another exemplary embodiment of the presentinvention, a method of non-invasive treatment of cellulite includesidentifying fat lobuli 1307 and creating a sharp focal of ultrasoundenergy onto fat lobuli 1307. The focal of energy pierces fat lobuli 1307to create opening 1321, which then allows the flowing of a material outof fat lobuli 1307 through opening 1321. The method can further includeany of the additional method steps discussed herein.

In various embodiments, the energy is delivered at a treatment depthfrom about 0 mm to about 50 mm or about 1 mm to about 35 mm. Theultrasound energy can be in the range from about 750 kHz to about 20 MHzand may be more useful in the range from about 2 MHz to about 10 MHz.The power of the ultrasound energy may be in a range from about 1 W toabout 50 W and may be more useful in the range from about 2 W to about20 W. The duration of the ultrasound energy may be in the range fromabout 10 milliseconds to about 20 minutes.

Once the treatment protocol, for any of the methods of treatmentdiscussed herein or variations thereof, has been implemented, ROI 210may have one or more reactions to the treatment. For example, in someembodiments, the tissue responds by enhancement of lymphatic drainage,evacuation of fat decay products, creation of a thermal injury and/orcoagulation of proximal protrusions of fat lobuli 1307.

In an exemplary embodiment, energy such as ultrasound energy is emittedfrom a treatment system at multiple depths to target numerous areaswithin a specific ROI 210. Multiple layers of tissue within ROI 210 aretreated from the surface down to the deepest point of ultrasound energypenetration and no intervening layers of tissue are spared in oneembodiment of the present invention. In addition to ultrasound energy,other energy forms such as laser energy, radio frequency energy, andother energies can be used and fall within the scope of the presentinvention. Further, blue light at a wavelength of approximately 400 to450 nm can be used to pre-treat ROI 210 before the application ofultrasound energy or blue light of this wavelength can be used withultrasound to increase the efficacy of treatment. In another embodiment,visible light in the range of 600 to 1350 nm can be used with theultrasound during treatment.

Upon treatment, the steps outlined herein can be repeated one or moreadditional times to provide for optimal treatment results. Differentablation sizes and shapes of conformal lesion 209 may affect therecovery time and time between treatments. For example, in general, thelarger the surface area of conformal lesion 209, the faster therecovery. The series of treatments can also enable the user to tailoradditional treatments in response to a patient's responses to theultrasound treatment.

The methods of treatment described herein can employ various shapedconformal lesions 209 and can be produced using the various acousticlenses and designs described herein. For example, mushroom shapedlesions may be produced from a spherically-focused source, and/or planarlesions from a flat source. That is, as the application of ablativeultrasound energy continues, this causes thermal expansion to generate agrowing lesion. Concave planar sources and arrays can produce a“V-shaped” or ellipsoidal lesion. Electronic arrays, such as a lineararray, can produce defocused, planar, or focused acoustic beams that maybe employed to form a wide variety of additional lesion shapes atvarious depths. Other lesion shapes that may be useful with thetreatment methods described herein include the lesion shapes andpatterns described in the U.S. patents and U.S. patent application thatare incorporated by reference herein.

The citation of references herein does not constitute admission thatthose references are prior art or have relevance to the patentability ofthe invention disclosed herein. All references cited in the Descriptionsection of the specification are hereby incorporated by reference intheir entirety for all purposes. In the event that one or more of theincorporated references differs from or contradicts this application,including, but not limited to, defined terms, term usage, describedtechniques, or the like, this application controls.

The present invention has been described above with reference to variousexemplary embodiments. However, those skilled in the art will recognizethat changes and modifications may be made to the exemplary embodimentswithout departing from the scope of the present invention. For example,the various operational steps, as well as the components for carryingout the operational steps, may be implemented in alternate waysdepending upon the particular application or in consideration of anynumber of cost functions associated with the operation of the system,e.g., various steps may be deleted, modified, or combined with othersteps. These and other changes or modifications are intended to beincluded within the scope of the present invention, as set forth in thefollowing claims.

What is claimed is:
 1. A method of non-invasive ultrasound fatreduction, comprising: imaging a region of interest with an imagingelement, wherein the image is displayed on a display, wherein the regionof interest comprises a plurality of fat lobuli and at least one of adermis tissue and a muscle tissue; delivering ultrasound energy with atherapy element at a depth below a skin surface to thermally lesion atleast a portion of one of the fat lobuli and at least one of the dermistissue and the muscle tissue; moving the therapy element to generatemultiple thermal lesions in the plurality of fat lobuli via a controlsystem comprising a processor, a power supply, and an encoder, whereinthe control system controls a motion mechanism attached to the therapyelement, wherein the imaging element and the therapy element areprovided within a single ultrasound probe; and wherein the thermallesion reduces fat.
 2. The method according to claim 1, the ultrasoundenergy is delivered at an energy level sufficient for causing at leastone of stretching fibrous bonds or stimulating evacuation of fat decayproducts in the region of interest.
 3. The method according to claim 1,further comprising coagulating at least one of a portion of the fatlobuli, a portion of the muscle tissue, and a portion of the dermislayer.
 4. The method according to claim 1, further comprising applying aphysical treatment to the skin surface, wherein the physical treatmentis at least one of massage and low frequency ultrasound.
 5. The methodaccording to claim 1, wherein the step of delivering ultrasound energygenerates a thermal lesion having a dimension of between 100 microns to55 mm in the region of interest, and wherein the ultrasound energy isdelivered in the range of 2 MHz to 10 MHz.
 6. The method according toclaim 1, wherein delivering ultrasound energy heats the region ofinterest to a temperature in a range from 43° C. to 49° C.
 7. A methodof non-invasive ultrasound fat reduction comprising: identifying aregion of interest, wherein the region of interest comprises a pluralityof fat lobuli and at least one of a dermis tissue and a muscle tissue;delivering ultrasound energy from a transducer element to the region ofinterest to create a thermal injury in a portion of the fat lobuli andat least one of the dermis tissue and the muscle tissue, wherein thetransducer element is positioned within a probe, wherein the transducerelement is attached to a motion mechanism, wherein the motion mechanismis positioned within the probe, wherein the motion mechanism iscontrolled by a control system, wherein the motion mechanism comprisesan encoder, and using the motion mechanism to move the transducerelement, thereby creating additional thermal injuries through additionaldelivering ultrasound energy from the transducer element to the regionof interest, wherein the thermal injuries cause breakage of the fatlobuli, thereby reducing fat.
 8. The method according to claim 7,further comprising imaging the fat lobuli with an imaging element,wherein the imaging element and the therapy element are combined in theprobe.
 9. The method according to claim 7, wherein the thermal injuriescoagulate a portion of the fat lobuli at a depth in the region ofinterest.
 10. The method according to claim 7, wherein the thermalinjury in the region of interest has a dimension of between 100 micronsto 55 mm to cause breakage of at least a portion of the fat lobuli. 11.The method according to claim 7, wherein the step of deliveringultrasound energy is delivered to the region of interest is in the rangeof 2 MHz to 10 MHz and heats the region of interest to a temperature ina range from 43° C. to 49° C.
 12. The method according to claim 7,further comprising imaging the fat lobuli with an imaging element,wherein the imaging element and the therapy element are combined in theprobe, wherein the image is displayed on a display, wherein theultrasound energy is delivered at an energy level sufficient for causingat least one of coagulating tissue, stretching fibrous bonds, andstimulating evacuation of fat decay products at a depth in the region ofinterest, wherein the thermal injury in the region of interest has adimension of between 100 microns to 55 mm to cause breakage in at leasta portion of the fat lobuli, and wherein the step of deliveringultrasound energy is delivered to the region of interest is in the rangeof 2 MHz to 10 MHz.
 13. A method of non-invasive ultrasound fatreduction comprising: providing an ultrasound system comprising anultrasound probe, a transducer housed within the probe, a motionmechanism within the probe, and an imaging element, the ultrasoundsystem configured for: (i) imaging a region of interest under a skinsurface with the imaging element, wherein the region of interestcomprises a plurality of fat lobuli and at least one of a dermis tissueand a muscle tissue; (ii) delivering ultrasound energy with thetransducer to thermally injure the plurality of fat lobuli and at leastone of the dermis tissue and the muscle tissue in the region of interest(iii) using the motion mechanism to move the transducer to form aplurality of thermal lesions at a depth to cause a reduction of the fatlobuli, wherein the motion mechanism comprises an encoder, wherein themotion mechanism is controlled by a control system.
 14. The methodaccording to claim 13, wherein the ultrasound energy coagulates theportion of the fat lobuli and at least one of the dermis tissue and themuscle tissue in the region of interest.
 15. The method according toclaim 13, wherein the thermal lesions have a dimension of between 100microns to 55 mm in the region of interest, wherein the ultrasoundenergy has a frequency in the range of 2 MHz to 10 MHz, and wherein atleast one of the thermal lesions coagulates the portion of the fatlobuli and at least one of the dermis tissue and the muscle tissue inthe region of interest.
 16. The method according to claim 13, whereinthe ultrasound energy ablates at least a portion of the fat lobuli inthe region of interest.
 17. The method according to claim 13, whereindelivering ultrasound energy heats the region of interest to atemperature in a range from 43° C. to 49° C., and the ultrasound energybreaks fat cell clusters in the region of interest.
 18. The methodaccording to claim 13, wherein delivering ultrasound energy heats theregion of interest to a temperature in a range from 43° C. to 49° C. andthe ultrasound energy stretches fibrous bonds in the region of interest.19. The method according to claim 13, wherein the imaging element andthe transducer are provided within the ultrasound probe.
 20. The methodaccording to claim 13, wherein the ultrasound energy has a frequency inthe range of 2 MHz to 10 MHz, wherein the thermal lesions have adimension of between 100 microns to 55 mm in the region of interest,wherein the imaging element and the transducer are provided within theultrasound probe, wherein the thermal lesions coagulate the portion ofthe fat lobuli and at least one of the dermis tissue and the muscletissue in the region of interest.